Principal Investigator.FL Licensed Physician. - Optimus U

The primary responsibility of the Investigator is to manage all clinical aspects of assigned clinical trials. The Investigator is required to have an in-depth knowledge of the protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the Investigator may act as liaison between the research coordinator and the sponsor. The Investigator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the investigator is responsible for all data and source documentation and adverse experience documentation and reporting.

Qualifications

Medical Doctor with ACTIVE Florida License. MD or DO

Sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements (e.g. subject follow up, reporting of adverse drug experience).
Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, and study related communications.
Organizational management of all aspects of the trials, including but not limited to timeliness in enrolling subjects, reporting adverse drug experiences (AEs and SAEs), managing caseload and managing study files.
Communications of all protocol related issues/problems to the appropriate management staff including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible AEs/SAEs or subject compliance.
Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
Specific responsibilities include but are not limited to the following:

Responsible for Protecting the rights, safety and welfare of all subjects
Provide both emergent and non-emergent medical care to subjects
Complete of training on specific rating scales prior to the commencement of any study procedures
Assess Adverse Events and Serious Adverse Events as needed
Administer the Informed Consent process to potential subjects per site SOP guidelines. Ensure the current approved informed consent form is signed.
Attend meetings related to the study, such as but not limited to: Pre-study Meetings, Site Initiation Visits, Monitoring Visits, Close-out Visits Investigator meetings.
Provide training to site staff on all assigned protocols and study procedures.
Provide guidance to staff/recruitment and answer any protocol-related enrollment issues.
Responsible for assisting in any discussion of medical or protocol-related issues with the medical monitor
Must be present on all initial doses and supervising any IV administrations
Conduct Physical Exams
Review labs and EKGs
Confirming subjects eligibility prior to enrollment into the study
Ensuring subjects continue to meet eligibility throughout the study.
Assessing out of range vitals
Assessing medical records to confirm patient eligibility.
Develop enrollment/follow-up mechanism
Possess a sound and in depth understanding of each protocol that has been assigned as a primary responsibility.
Review the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
Review the protocol summary sheet and the informed consent form for accuracy and clarity.
Develop draft protocol source documents and then review the worksheets for accuracy and clarity or review the source documents as prepared by selected staff for accuracy and clarity.
Enroll and follow-up of study subjects
Screening and enrollment procedures
Review and verify all relevant source documentation in the subject record to confirm study eligibility.
Review the protocol, informed consent form, and follow-up procedure with potential study subjects.
Ensure the randomization procedure is followed as per protocol guidelines.
Document protocol exemptions and deviations as appropriate.
Ensure adherence to protocol visits.
Schedule subjects for follow-up visits.
Assess subject response to therapy and evaluate for AEs.
Assess and document subject compliance with medications and visits. Communicate with pharmacy staff as needed to assure timely and accurate study drug distribution.
Administer study drug therapy as needed (as legally appropriate).
Maintain copies of all prescriptions written for study drug supplies as appropriate.
Ensure appropriate specimen collections.
Communicate regularly with monitors about study related issues.
Maintain source documentation for all CRF entries, including clinical chart visit notes, lab data, and procedure reports.
Ensure data is available to data entry personnel in a timely manner.
Assure queries or data clarification forms are routed to data entry personnel in a timely manner.
Report all serious AEs to the coordinator, sponsors monitor, and IRB as outlined in the protocol or other source (e.g. IRB requirements).
Communicate SAEs to data entry personnel to ensure entry into the CRF within protocol required timelines.
Regulatory documentation
Forward regulatory documents to Regulatory and maintain copies of all relevant regulatory documents.
Act as backup to regulatory for all assigned studies.
Sponsor and/or FDA audits
Ensure that all required documentation is complete and appropriately filed.
Provide all required documentation to auditors.
Make all appropriate corrections as requested by auditors.
Management of ancillary staff
Ensure all patients have completed every part of their visit before exiting the institution
Employment Type: Full-Time